On November 2, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the quarter ended September 30, 2021 and highlighted recent events (Press release, GlycoMimetics, NOV 2, 2021, View Source [SID1234594136]). Cash and cash equivalents at September 30, 2021 were $101.9 million.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"I am excited about the strong momentum and opportunities we have in front of us. I am grateful for the dedication and perseverance of our employees and board of directors especially during my CEO transition period," commented Chief Executive Officer Harout Semerjian.
Operational Highlights
Uproleselan
Enrollment of GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML continued in the U.S., Canada, Australia and Europe at a robust pace throughout the third quarter of 2021. The Company anticipates imminent completion of enrollment with top line data anticipated after year-end 2022.
The ongoing National Cancer Institute (NCI)-sponsored Phase 2/3 registration trial, designed to evaluate the use of uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy is anticipated to complete enrollment of the Phase 2 portion by year-end, allowing for an interim Event-Free Survival analysis of 262 patients.
Efficacy and safety data from a Phase 1/2 clinical study of uproleselan were published online September 16, 2021 in BLOOD. Investigators highlighted an analysis that reported an MRD negative rate of 69 percent in evaluable trial participants with relapsed/refractory AML, indicating an enhanced depth of response following addition of uproleselan to salvage therapy.
The Company has had interactions with the U.S. Food and Drug Administration (FDA) under the Breakthrough Therapy Designation to align on key elements of the CMC program in advance of a new drug application (NDA) submission. Consistent with that guidance, uproleselan drug product registration batches have been completed.
GMI-1687
The Company continued to advance GMI-1687 towards filing of an investigational new drug application (IND), anticipated in the first half of 2022. It has been shown in preclinical studies to be bioavailable via subcutaneous administration with potential clinical applications in vaso-occlusive crisis of sickle cell disease as well as a potential life-cycle extension opportunity for uproleselan.
Management
The GlycoMimetics Board of Directors appointed Harout Semerjian as Chief Executive Officer and President, effective August 6, 2021, to succeed retiring founder Rachel King, who is continuing to serve on the Company’s board. Mr. Semerjian, a seasoned executive with strong oncology commercialization experience, now leads the Company as it advances its registrational trials for uproleselan in AML, accelerates planning for potential commercialization, and continues to build out the Company’s pipeline.
Third Quarter 2021 Financial Results
Cash position: As of September 30, 2021, GlycoMimetics had cash and cash equivalents of $101.9 million as compared to $137.0 million as of December 31, 2020.
R&D Expenses: Research and development expenses increased to $13.3 million for the quarter ended September 30, 2021 as compared to $10.7 million for the quarter ended September 30, 2020. This increase was primarily due to an increase in clinical trial costs in the ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML.
G&A Expenses: General and administrative expenses were $4.1 million for the quarter ended September 30, 2021 and 2020.
Shares Outstanding: Shares of common stock outstanding as of September 30, 2021 were 51,734,894.
The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 2991493. Participants are encouraged to connect 15 minutes in advance of the call to ensure they are able to connect. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 domestic participants and (404) 537-3406 for international participants, with participant code 2991493.
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.
About GMI-1687
Discovered and developed by GlycoMimetics, GMI-1687 is a highly-targeted, highly-potent E-selectin antagonist that represents a potential life-cycle extension opportunity for uproleselan. It has been shown in preclinical studies to be bioavailable via subcutaneous administration, and could be a potentially self-administered drug to be used in treatment of AML. Additionally, data from recent oral presentations at major scientific conferences pointed to the potential for GMI-1687 as a self-administered drug to treat vaso-occlusive crisis of sickle cell disease.